Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc.

Testing expired samples and conducting “uncontrolled experiments” on non-expired samples lead to a finding of non-infringement.

January 23, 2017

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Merck Sharp & Dohme Corp. v. Teva Pharms. USA, Inc., No. 14-874-SLR, 2016 U.S. Dist. LEXIS 158514 (D. Del. Nov. 16, 2016) (Robinson, J.)

Drug Product and Patent(s)-in-Suit: Nasonex® (mometasone furoate monohydrate (“MFM”)); U.S. Patent No. 6,127,353 (“the ’353 patent”)

Nature of the Case and Issue(s) Presented: Whether Teva’s ANDA product infringes the ’353 patent, and whether that patent is valid. The infringement argument related to whether the accused ANDA product—over its two-year shelf life—contained the claimed MFM or only anhydrous mometasone furoate (“MFA”), a prior-art polymorph of MFM. The court found that patent valid and not infringed.

Why Teva Prevailed: Teva prevailed by convincing Judge Robinson that Merck’s analysis of two types of samples of the ANDA product was insufficient to establish the presence of MFM during the product’s two-year shelf life. The court concluded that due to the unreliability of tests for distinguishing polymorphs, Merck was required to find MFM using both polarized optical microscopy and x-ray diffraction.

First, Merck analyzed various expired samples of the product. It purported to find the MFM polymorph in the expired samples, using both microscopy and x-ray diffraction. Although Merck’s expert concluded that the observed MFM crystal size increased with time post-manufacturing, the court observed that he had not performed any kinetics studies and so was unable to reliably extrapolate back to a time before the expiration of the shelf-life. Thus, the court rejected the infringement proof based on the expired samples.

Merck also presented data for unexpired samples. These samples tested positive for MFM using microscopy. They also tested positive using x-ray diffraction. But the court discounted this data. In order to find samples sufficiently large for the x-ray diffraction test, Merck’s expert allowed the liquid ANDA product to crystalize on glass slides. Teva’s expert, however, characterized this as an “uncontrolled experiment,” saying that nucleation on the slides could have created MFM crystals not present in the ANDA product. The court thus concluded that Merck had not met its burden, and found non-infringement.

Concerning the issue of validity, Teva challenged the ’353 patent’s validity in two ways. First, it alleged non-statutory double patenting, basing its argument on a Merck patent that was a direct continuation of the asserted patent. This patent expired before the asserted patent, but this early expiration was due to the abandonment and revival of the underlying application. The court, saying, “[t]his is not an instance of a patentee seeking to extend the patent term with ‘sequential’ applications, rejected  Teva’s argument. Second, Teva alleged that certain claims were invalid for failing to meet the written description requirement. Merck defended by arguing that an incorporated-by-reference patent provided the necessary support. The court agreed, discounting Teva’s argument that the incorporated patent only showed a procedure for making MFM. Rather, the court held that the entire patent was incorporated. It then noted that Teva’s expert had not addressed the teachings of the incorporated patent, and then concluded that Teva had failed to meet its burden.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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